February 24, 2017 3:07 PM ET

Pharmaceuticals

Company Overview of Breckenridge Pharmaceutical, Inc.

Company Overview

Breckenridge Pharmaceutical, Inc. engages in the research, development, marketing, and distribution of generic prescription products in various therapeutic categories. The company markets its generic prescription products in various dosage forms, including tablets, capsules, soft gel capsules, liquids, suspensions, ophthalmics, nasal sprays, and powders, as well as focuses on the provision of injectables, transdermals, inhalers, and topicals. It also provides various medical foods for the dietary management of patients with therapeutic or chronic medical needs; and prenatal and dietary supplements. In addition, the company handles various aspects of business operations, including procurement...

6111 Broken Sound Parkway NW

Suite 170

Boca Raton, FL 33487

United States

Founded in 1983

Phone:

561-443-3314

Fax:

561-989-9747

Key Executives for Breckenridge Pharmaceutical, Inc.

Executive Director of Operations
Senior Vice President of Sales & Marketing-New Jersey Office
Vice President of Finance for CT Office
Associate Director of Technical Services for CT Office
Compensation as of Fiscal Year 2016.

Breckenridge Pharmaceutical, Inc. Key Developments

Breckenridge Pharmaceutical, Inc. Announces Final ANDA Approval for Bendamustine HCl Powder for IV (Treanda)

Breckenridge Pharmaceutical, Inc. announced that FDA has granted final approval of its ANDA bendamustine hydrochloride powder for IV (infusion), 25 mg/vial and 100 mg/vial, a generic version of Treanda by Cephalon, Inc. Breckenridge, and its development and manufacturing partner Natco Pharma Limited, filed the ANDA with Paragraph IV certification on the first-to-file date and expect to share 180-day exclusivity with other ANDA first filers. Pursuant to settlement of the Paragraph IV litigation, Breckenridge intends to launch the ANDA on November 1, 2019, or earlier based on certain circumstances. Treanda is a prescription drug that is indicated to treat chronic lymphocytic leukemia and non-Hodgkin's lymphoma. Treanda powder for IV (infusion) generated sales of $133 million for the twelve-month period ending November, 2016 based on industry sales data.

Breckenridge Pharmaceutical, Inc. Enters into Multi-Product Marketing Agreement with Gland Pharma Limited for Seven Injectable Products

Breckenridge Pharmaceutical, Inc. announced that it has entered into a multi-product marketing agreement with Gland Pharma Limited for seven injectable products. Under the terms of this agreement, Breckenridge will market and distribute the products under its label in the United States. The deal includes six approved ANDA's and one tentatively-approved ANDA. The products cover a wide range of indications.

Breckenridge Launches Armodafinil Tablets with its Partner Natco Pharma Limited

Breckenridge Pharmaceutical, Inc. announced that it has launched its ANDA for Armodafinil tablets (CIV) in 50mg, 150mg and 250mg strengths on November 28, 2016, after having received final approval by FDA.  Armodafinil tablets is a generic version of Nuvigil® by Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd.  Breckenridge and Cephalon entered into a confidential settlement which includes a license to market its ANDA effective 180 days after the initial launch of generic versions of Nuvigil®.  Breckenridge is launching Armodafinil tablets with its partner Natco Pharma Limited, who is owner of the ANDA. Breckenridge's Armodafinil tablets are AB-rated to Nuvigil®, a prescription medicine indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD).

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